Honourable Minister of Health,
Respected Vice-Minister of Health,
World Health Organization representatives,
Distinguished dignitaries, guests, ladies and gentlemen
Good Afternoon. I am pleased today to announce that after careful review by WHO experts, Viet Nam is now recognized as having a functional national regulatory authority for vaccines.
The certification is based on the assessment an international team of independent experts that worked with WHO during April.
This is a significant achievement for Viet Nam. Their exceptional results should give everyone confidence in the safety and efficacy of vaccines made in Viet Nam.
I came here today to personally deliver a letter signed by the Director-General of the World Health Organization, Dr Margaret Chan, highlighting the exceptional findings and recommendations.
Based on these results, local vaccine producers in Viet Nam may now apply for WHO prequalification of their vaccines.
Assessments of Viet Nam's vaccine regulatory authority began in 2001. The Ministry of Health established a road map and an institutional development plan that were revised periodically.
Progress has accelerated, however, since 2013 when Viet Nam requested a full assessment of eligibility for prequalification of local vaccines by WHO.
In response, WHO scaled up its technical support, providing guidance and helping mobilize resources to strengthen the country's capacity. Our combined efforts have been tremendously successful.
Now Viet Nam's status as a fully functioning vaccine regulatory authority allows national vaccine producers to apply for WHO prequalification of locally produced vaccines.
Viet Nam is one of only 37 countries in the world to achieve this status.
The job of regulatory oversight rests with Government — to work with vaccine manufacturers to ensure that vaccines are safe and effective and produced according to international standards established by WHO.
This is an immense job with that saves literally millions of lives.
A vaccine regulatory authority must oversee and approve every step of the journey that a vaccine takes — from clinical trials for safety and efficacy, to manufacturing facilities and equipment — right down to approving the manufacturing process. Only then can a vaccine be licensed and allowed on the market.
The regulatory responsibilities do not stop with manufacturing. They continue throughout the life of the vaccine. Every batch produced is tested chemically and biologically for quality assurance before its release for use.
The safety of vaccines already in use is also monitored through an adverse event following immunization surveillance system.
The regulator has the responsibility and authority to intervene whenever a problem is identified.
Viet Nam's recent evaluation means that all these functions are being performed at a level that meets or exceeds international standards.
I would like to once again congratulate Viet Nam for your hard work and dedication in establishing a robust vaccine regulatory authority.
The real winners are the children of Viet Nam who will benefit even more from the life-saving power of immunization.
This accomplishment will also benefit people throughout the Region and the world, as vaccine manufacturers in Viet Nam can now contribute to increasing global supplies to ensure that everyone has access to quality vaccines.
Dozens of vaccines are currently produced locally. Once these are evaluated and prequalified by WHO, suppliers can participate in an international marketplace of more than 150 countries through WHO and the United Nation’s vaccine procurement system.
Together, WHO and Member States are turning words into actions that save lives.
Working together with Member States like Viet Nam to strengthen health systems throughout the Region, I am proud of our progress towards bringing the life-saving benefits of immunization to all the more than 1.8 billion people in the Western Pacific Region.
Thank you.